长沙 [切换城市] 长沙招聘长沙生物/制药/医疗器械招聘长沙药品生产/质量管理招聘

助理质量经理/ 高级质量专员

碧迪医疗器械(上海)有限公司

  • 公司规模:1000-5000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2017-03-01
  • 工作地点:上海
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:本科
  • 职位月薪:8+ 千/月
  • 职位类别:药品生产/质量管理  

职位描述

职位描述:
POSITION SUMMARY
The position is also responsible for maintaining the company’s quality systems including the trading company systems, supply chain and distribution center quality management, supplier management, etc. He/she is to ensure that the quality system compliance requirements are met per the corporate and local regulation requirements.

KEY RESPONSIBILITIES
1. Responsible for maintaining the company’s quality systems and the quality management in the distribution center and supply chain, including supplier audit, etc.;
2. Responsible for Control of Documents and Records and ensure that the quality system documentation, forms and records comply with all applicable standards and regulations;
3. Responsible for review and update when necessary the BD’s quality documents in accordance with quality related laws and regulations etc.;
4. Responsible for disseminating quality procedures and scheduling and tracking associated training;
5. Responsible for the Nonconformance procedure management and follow up;
6. Responsible for collecting, trending and disseminating quality indicators, including but not limited to quality objectives, service levels, distribution, training and complaints;
7. Initiate, track, follow-up and close Corrective and Preventive Actions;
8. Co-ordinate, schedule and follow-up Management Reviews and site audits;
9. Other related work assigned by the manager.

SKILLS AND ABILITIES
1. At least 3 years’ quality assurance experience in the pharmaceutical or medical device industry;
2. Relevant experience in quality systems for failure investigation, corrective & preventive action, and quality document & record management;
3. Experience in trading company, supply chain/warehouse quality systems;
4. Fluent in spoken and written English;
5. Good communication skills;
6. Teamwork;
7. Drive for results and action oriented with a high sense of urgency.

DESIRABLE
1. Familiar with the CFDA quality system requirements, e.g. AE reporting, recall regulation, GSP, labeling requirements for the imported medical devices etc.;
2. Knowledge in ISO 9000:2008, ISO 13485:2016 or US FDA QSR will be an advantage;
3. Good English communication skills, computer skills, excel, Access, PowerPoint etc.

职能类别: 药品生产/质量管理

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公司介绍

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.

关于BD

BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者,致力于通过研发创新技术、服务和解决方案,帮助患者改善临床治疗,并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念,致力于帮助提升患者的治疗效果,为临床医护人员提供安全、高效的护理给药流程,协助实验室科学家们更有效地诊断疾病,并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构,与全球范围内的组织机构积极合作,携手应对最具挑战的全球健康问题。通过与客户的紧密协作,BD以改善治疗结果,降低医疗成本,提升诊断效率为己任,帮助加强患者和医护人员的安全并扩大医疗可及性。2017年,BD欢迎巴德及其产品加入BD大家庭。更多信息,敬请访问**********/china。

联系方式

  • Email:club@51job.com
  • 公司地址:中国上海市浦东新区东育路221弄11号前滩世贸中心三期B栋12-18楼 (邮编:200040)